Impact of Alpha-Lipoic Acid Ingestion on Glucose Tolerance in Subjects With Pre-Diabetes
Primary Purpose
PreDiabetes
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
alpha lipoic acid
Cellulose
Sponsored by
About this trial
This is an interventional treatment trial for PreDiabetes focused on measuring pre-diabetes, glucose, insulin, blood lipids, alpha lipoic acid
Eligibility Criteria
Inclusion Criteria:
- sedentary individuals (exercises < 2 days/week)
- fasting blood glucose between 100-125 mg/dl (pre-diabetes)
- BMI of 25-40.
Exclusion Criteria:
- physically active lifestyle (exercise > two days/week)
- pregnancy
- history of cigarette smoking
- medication and/or dietary supplement to control blood glucose, lipids, or blood pressure.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Control Phase
Experimental Phase
Arm Description
cellulose (600 mg)
alpha lipoic acid (600 mg)
Outcomes
Primary Outcome Measures
Glycemic control
blood glucose and insulin
Secondary Outcome Measures
Blood lipids
Blood cholesterol
Blood lipids
Triglycerides
Full Information
NCT ID
NCT03612037
First Posted
July 16, 2018
Last Updated
November 27, 2020
Sponsor
State University of New York at Buffalo
1. Study Identification
Unique Protocol Identification Number
NCT03612037
Brief Title
Impact of Alpha-Lipoic Acid Ingestion on Glucose Tolerance in Subjects With Pre-Diabetes
Official Title
Impact of Alpha-Lipoic Acid Ingestion on Glucose Tolerance in Subjects With Pre-Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
September 1, 2016 (Actual)
Primary Completion Date
December 30, 2018 (Actual)
Study Completion Date
December 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
State University of New York at Buffalo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Obesity, with a prevalence of over 35% in American adults, is considered the most critical threat to the health and well-being of Americans. Obesity-associated metabolic abnormalities, including hyperglycemia, insulin resistance, and dyslipidemia, contribute substantially to elevated risk of cardiovascular disease (CVD) and diabetes. Although significant and sustained lifestyle modifications in diet and exercise are effective in reducing weight and improving obesity-related metabolic disturbances, long-term compliance to drastic changes in diet and daily activity patterns is often difficult to attain given the hectic lifestyle of modern societies. Health-promoting nutraceuticals - naturally occurring bioactive compounds capable of eliciting targeted molecular responses at the cellular level - may be an effective and convenient strategy to assist in weight reduction and reduce disease risk factors in obese individuals. Furthermore, nutraceutical compounds could prove to be a powerful adjunct to lifestyle and pharmacological weight reduction therapies, as they are relatively safe, cost effective, and possess the ability to modulate specific, and sometimes multiple, molecular targets. As a dietary supplement, alpha-lipoic acid appears to have broad molecular specificity with an impressive array of metabolic health benefits that include weight loss, reduction in blood lipids, and improved glycemic control. As the effects of alpha-lipoic acid supplementation for dyslipidemia, hyperglycemia, and body composition through appetite suppression and increased energy expenditure have been repeatedly confirmed in multiple animal models, it is surprising that there has been limited effort to translate these responses to human subjects. Given the strong pre-clinical data supporting the health benefits of alpha-lipoic acid, there is a clear need to conduct controlled interventions to address the current clinical knowledge gap and assess if the anti-diabetic effect of α-lipoic acid can be translated to humans.
The primary objective of this application is to determine the efficacy of alpha-lipoic acid supplementation on glycemic control and body composition in obese pre-diabetic adults. The investigators hypothesize that alpha-lipoic acid supplementation will improve biomarkers of diabetes and cardiovascular risk and promote changes in body composition in obese adults.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PreDiabetes
Keywords
pre-diabetes, glucose, insulin, blood lipids, alpha lipoic acid
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Phase
Arm Type
Placebo Comparator
Arm Description
cellulose (600 mg)
Arm Title
Experimental Phase
Arm Type
Experimental
Arm Description
alpha lipoic acid (600 mg)
Intervention Type
Dietary Supplement
Intervention Name(s)
alpha lipoic acid
Intervention Description
600 mg/day oral dose of alpha lipoic acid
Intervention Type
Dietary Supplement
Intervention Name(s)
Cellulose
Intervention Description
600mg/day oral dose of placebo cellulose
Primary Outcome Measure Information:
Title
Glycemic control
Description
blood glucose and insulin
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Blood lipids
Description
Blood cholesterol
Time Frame
1 month
Title
Blood lipids
Description
Triglycerides
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
sedentary individuals (exercises < 2 days/week)
fasting blood glucose between 100-125 mg/dl (pre-diabetes)
BMI of 25-40.
Exclusion Criteria:
physically active lifestyle (exercise > two days/week)
pregnancy
history of cigarette smoking
medication and/or dietary supplement to control blood glucose, lipids, or blood pressure.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Impact of Alpha-Lipoic Acid Ingestion on Glucose Tolerance in Subjects With Pre-Diabetes
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